Clinical Trial Support

Insight Genetics has a proven track record for taking a diagnostic target from biomarker discovery through test design, development and clinical validation. Along with our adaptability and platform flexibility to suit multiple indications, Insight is an ideal partner for clinical trials.

CLINICAL TRIAL TESTING SERVICES
Insight Genetics’ clinical trial testing support services can help you during any stage of assay design and development, clinical testing, and drug development. Our alignment with Clinical Research Organizations (CROs), Contract Manufacturing Organizations (CMOs), and regulatory experts ensures the appropriate parties are folded into the team at the right time throughout the drug development process.
 
Insight Genetics provides the following services:

  • PRE-CLINICAL
    • Biomarker Discovery/Development
    • Assay Design and Development for Research Assay
    • Clinical Trial Strategy Design to Include Diagnostic
  • PHASE I
    • Early-Phase Patient Screening
    • Sample Collection Management 
    • Data Management 
    • Assay Redesign, if Necessary
    • Pre-Sub Meeting (IND/IDE)
    • Assay CLIA Validation for Clinical Trial Assay
  • PHASE II
    • Regulatory Support for IDE Process
    • Target Patient Population Identification
    • Sample Collection Management 
    • Data Management 
    • Clinical Trial Testing Services Under CLIA Guidelines
    • CMO Identification for Research Use Only Kit
  • PHASE III
    • Target Patient Population Identification 
    • Sample Collection Management 
    • Data Management
    • Ex-U.S. Regulatory Submission (e.g. CE-marking) 
    • PMA, NDA Submission 
    • Drug Approval
    • Global Diagnostic Manufacturing and Commercialization Strategy

To discuss how we can assist your organization during the clinical trial process, please contact us.